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Singapore HSA registration DE0015999

Remel Escherichia coli Agglutinating Sera

Singapore flagSingapore·CLASS B IVD·Remel Europe Limited·Registered July 17, 2014
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration information
Registration Number
DE0015999
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product description
Escherichia coli Agglutinating Sera are intended for use in agglutination tests for the presumptive identification of E. coli serotypes traditionally associated with infantile gastroenteritis. However, since antigenic components are shared widely throughout the Enterobacteriaceae it is important to confirm by biochemical tests that an organism is of the species E. coli when attempting serological identification.
Product Owner
Name
Remel Europe Limited
Short Name
Remel Europe Limited
Address
Remel House, Clipper Boulevaard West, Crossways, Dartford, Kent DA2 6PT, UNITED KINGDOM
Registrant
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
Model Name(s)
E. coli Polyvalent 2 Agglutinating Sera E. coli Polyvalent 3 Agglutinating Sera E. coli Polyvalent 4 Agglutinating Sera E. coli type O26: K60 (B6) Agglutinating Sera E. coli type O44: K74 (L) Agglutinating Sera E. coli type O55: K59 (B5) Agglutinating Sera E. coli type O86: K61 (B7) Agglutinating Sera E. coli type O111: K58 (B4)) Agglutinating Sera E. coli type O112: K66 (B11) Agglutinating Sera E. coli type O114: K90 (B) Agglutinating Sera E. coli type O119: K69 (B14) Agglutinating Sera E. coli type O124: K72 (B17) Agglutinating Sera E. coli type O125: K70 (B15) Agglutinating Sera E. coli type O126: K71 (B16) Agglutinating Sera E. coli type O127: K63 (B8) Agglutinating Sera E. coli type O128: K67 (B12) Agglutinating Sera E. coli type O142: K86 (B) Agglutinating Sera E. coli type O18c: K77 (B21) Agglutinating Sera
Model Identifier(s)
R30954901 R30955001 R30955101 R30955201 R30955301 R30955401 R30955501 R30955601 R30955701 R30955801 R30955901 R30956001 R30956101 R30956201 R30956301 R30956401 R30956501 R30956601
About this record

Access comprehensive regulatory information for Remel Escherichia coli Agglutinating Sera in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0015999 and owned by Remel Europe Limited. The device was registered on July 17, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD